Director, Drug Product, Technical Operations (Princeton, NJ or Oxford, UK )

Summit Therapeutics plc•Princeton, NJ

41d•$184,000 - $230,000•Onsite

About The Position

About Summit Ivonescimab known as SMT112 is a novel potential first in class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD 1 with the anti angiogenesis effects associated with blocking VEGF into a single molecule Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD 1 and VEGF Summit has begun its clinical development of ivonescimab in non small cell lung cancer NSCLC with three active Phase III trials HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI eg osimertinib HARMONi 3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLC HARMONi 7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC whose tumors have high PD L1 expression Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe Ivonescimab was approved for marketing authorization in China in May 2024 Ivonescimab was granted Fast Track designation by the US Food & Drug Administration FDA for the HARMONi clinical trial setting Overview of Role We are seeking a highly experienced and strategic Director of Drug Product Technical Operations to lead late phase clinical and commercial manufacturing activities for our bispecific antibody sterile drug product This role is critical in supporting BLA readiness overseeing clinicalcommercial batch production and driving process and site changes in collaboration with MSAT The ideal candidate will bring deep expertise in biologics manufacturing sterile drug product operations and regulatory expectations

Requirements

Bachelors degree in Engineering Biochemistry Pharmaceutical Sciences or related field; PhD or MS preferred
Minimum of 12 years of experience in biologics manufacturing with a focus on sterile drug product and late phase development
Proven track record in BLA preparation PPQ and commercial launch
Strong knowledge of regulatory expectations FDA EMA for biologics
Experience managing external manufacturing partners and internal cross functional teams
Excellent leadership communication and project management skills

Responsibilities

Partner with MSAT to implement product process and site changes ensuring robust technical oversight and documentation
Lead end to end manufacturing operations for sterile drug product including oversight of CMOs and internal teams
Ensure successful execution of clinical batch manufacturing in alignment with development timelines and quality standards
Drive readiness for BLA filing and commercial launch including validation and PPQ strategy
Ensure successful execution of commercial batch manufacturing in alignment with supply plan and quality standards
Lead investigations and root cause analyses for manufacturing deviations and implement corrective actions
Develop and execute manufacturing strategies aligned with program milestones and regulatory requirements
Collaborate cross functionally with Regulatory Quality Supply Chain and CMC teams to ensure integrated planning and execution
Manage budgets timelines and resources for manufacturing operations
Ensure GMP compliance across all manufacturing activities
Support audits and inspections
Maintain strong documentation practices and contribute to regulatory submissions
All other duties as assigned